Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population

NCT07084935 | Recruiting

• 1 other identifier: 2025-18010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia. While both monitors are designed to assess nociceptive responses through autonomic nervous system activity, they differ in methodology and parameters measured. The NOL index integrates multiple physiological signals using a self-learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude. Although both have been studied individually in children, a direct comparison has not yet been conducted. This study will evaluate and compare each monitor's ability to detect and quantify nociceptive stimuli (surgical and tetanic) in children. The investigators hypothesize that the NOL monitor and SPI monitor will both be able to quantify surgical stimuli and tetanic stimuli with monitors response to surgical stimuli \> monitors response to tetanic stimuli. However, the investigators also hypothesize that the NOL index will do this superiorly, as it utilizes a self-learning algorithm and more parameters are incorporated in its algorithm

Conditions

Nociceptive Pain; Anesthesia; Pediatric Anesthesia; Nociception Monitoring

Keywords

Nociception monitoring; Pediatric population; NOL index; Surgical pleth index

Outcome Measures

Primary Outcomes (2)

• Change in surgical pleth index (∆SPI) during surgical stimuli and standardized tetanic stimuli

  ∆SPI = pre stimulus -30s-0s mean SPI value - post stimulus +5s to 30s-120s SPI value.

  During surgery with general anesthesia.

• Change in nociception level index (∆NOL) during surgical stimuli and standardized tetanic stimuli

  ∆NOL = pre stimulus -30s-0s mean NOL value - post stimulus +5s to 30s-120s NOL value.

  During surgery with general anesthesia

Secondary Outcomes (12)

• Change in surgical pleth index (∆SPI) following intraoperative opioid administration.

  During surgery with general anesthesia]

• Change in nociception level index (∆NOL) following intraoperative opioid administration.

  During surgery with general anesthesia

• Time NOL index is >25 and SPI is >40 during surgery and before intra-operative opioid administration. Defined as time NOL index is >20-25 and SPI is >40 during surgery time.

  During surgery with general anesthesia

• Comparing mean (total surgery time) and last 5-min mean values before disconnection for intra-operative NOL and SPI to the post-operative pain scores.

  perioperative/periprocedural

• Change in surgical pleth index (∆SPI) after administration of vasoactive medication.

  During surgery with general anesthesia

Study Arms (1)

Patients aged 1 to 12 years undergoing surgery with general anesthesia.

Device: Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI); Device: All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision

Interventions

Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI) DEVICE

All patients will be connected to the NOL and SPI during surgery after induction of general anesthesia.

Patients aged 1 to 12 years undergoing surgery with general anesthesia.

All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision DEVICE

All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision.

Patients aged 1 to 12 years undergoing surgery with general anesthesia.

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients scheduled to undergo surgery with general anesthesia at the Radboud university medical centre in Nijmegen, the Netherlands

You may qualify if:

• Male or female
• ASA I, ASA II and ASA III
• Aged 1 to 12 years old
• Scheduled to undergo elective surgery with general anaesthesia

You may not qualify if:

• Patients with chronic pain
• Patients with chronic analgesia usage.
• Known allergy to the adhesives used in the sensors.
• No free available limb to attach the probes to.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical centre

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ignacio Malagon, Professor

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cees klein Tank, Drs.

CONTACT

+31 (024) 365 57 55; cees.kleintank@radboudumc.nl

Ignacio Malagon, Professor

CONTACT

+31 (024) 365 57 55; ignacio.malagon@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. Jose Ignacio Malagon Calle MD, PhD

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 25, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

NL (1)